Novo seeks to strengthen Tresiba label in US

Studies find insulin degludec advantage over insulin glargine

Novo Nordisk has filed new data to the FDA showing its long-acting insulin Tresiba is less likely to cause low blood sugar levels or hypoglycaemia in patients with type 2 diabetes compared to Sanofi's Lantus.

The Danish drugmaker wants the results of the DEVOTE trial - which also backed up the cardiovascular safety of Tresiba (insulin degludec) - added to the US label for the drug, which has been in the ascendency after a late start in the market.

The trial showed that Tresiba was non-inferior to insulin glargine U100 (the active ingredient in Lantus) when major adverse cardiovascular events (MACE) - specifically the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke - was compared.

Interim results from the 7,500-patient DEVOTE study were instrumental in allowing Novo to get FDA approval for Tresiba and combination drug Ryzodeg in 2015, after being knocked back by the agency two years previously.

Despite the late start, Novo says it has been capturing market share from its rival and will be hoping that the final results from the study - particularly on hypoglycaemia rates - will help it maintain that momentum as the first biosimilar version of Lantus has now reached the US market, and in the face of downward pricing pressure.

Type 2 diabetics who need insulin to control their blood sugar are often fearful of experiencing hypoglycaemia, which can cause tiredness, confusion and in some cases even loss of consciousness. An earlier study - called SWITCH 2 - also found an advantage for Tresiba over Lantus on hypoglycaemia rates.

"The risk of severe hypoglycaemia is a major cause for people with type 2 diabetes not reaching their treatment targets," said Mads Krogsgaard Thomsen, Novo's chief science officer.

"With the DEVOTE data, we have demonstrated that the strong clinical profile of Tresiba leads to a significant reduction in severe hypoglycaemia in people with type 2 diabetes," he added.

Novo has already been forced to trim back staffing levels to reduce operating costs as it faces increased competition in its key diabetes franchise, but in its first-quarter results said Tresiba and other modern insulin products was seeing sales volumes ramp up thanks to improved reimbursement coverage in the US, as well as other markets such as Denmark and the Netherlands.

Sales of the drug rose 166% to 1.5bn Danish krone ($225m) in the first quarter of this year.